PMA P100034S006
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S006
- Product code
- NZK
- Decision date
- 2013-09-19
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- CHANGE TO THE MANUFACTURING PRODUCTION FLOW TO INCLUDE DISTRIBUTION LOGISTICS THAT WILL BE PERFORMED BY NOVOCURE GMBH IN ROOT LUZERN, SWITZERLAND.
Current openFDA PMA Record#
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S006
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2013-09-19
- Decision code
- OK30
- Date received
- 2013-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING PRODUCTION FLOW TO INCLUDE DISTRIBUTION LOGISTICS THAT WILL BE PERFORMED BY NOVOCURE GMBH IN ROOT LUZERN, SWITZERLAND.